Vastavam web: Johnson & Johnson said it has paused further dosing in all clinical trials of its experimental Covid-19 vaccine because a study volunteer had an unexplained illness. The pause announced Monday affects all trials of J&J’s vaccine, including a large Phase 3 trial that began in September and aimed to enroll as many as 60,000 people in the U.S. and several other countries. An independent data-safety monitoring board is reviewing the study subject’s illness, the company said. The company didn’t immediately disclose more information about the illness, and said it needed to respect the subject’s privacy.
J&J, of New Brunswick, N.J., said illnesses and other side effects are an expected part of any clinical study, and it has prespecified guidelines to monitor for the events. The guidelines “ensure our studies may be paused if an unexpected serious adverse event that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study,” the company said. Company officials had estimated the Phase 3 trial could begin providing results either by the end of the year or in early 2021, and the shots could be authorized for use in early 2021.